Home NDC 50090-7494 AZACTAM
Product NDC 50090-7494
11-digit product format 500907494
Labeler code 50090
Product ID 50090-7494_60269c3e-8d92-4584-bdfb-4f728c514e98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AZTREONAM
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler A-S Medication Solutions
Application NDA050580
Marketing category NDA
Marketing start 2010-04-01
Substance AZTREONAM
Active strength 1 g/1
Pharmacologic classes Monobactam Antibacterial [EPC], Monobactams [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050580-001 AZACTAM AZTREONAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 N050580-002 AZACTAM AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 N050580-003 AZACTAM AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050580-002 AZACTAM 1GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050580-003 AZACTAM 2GM/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050580-001 AZACTAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 1986-12-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base AZACTAM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZTREONAM 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G2B4VE5GH8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1664981 Internal RxNorm lookup 1664984 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-7494-0 AZACTAM 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 1 1 50090-7494-0 AZACTAM 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7494 AZACTAM (AZTREONAM) INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20250112_f9d5515e-54bc-4efc-9f49-8ee3e88c3e01.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-7494-0 50090749400 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-7494-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2025-01-08 No No Current